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For users of breathing machines made by Philips Respironics, recent years have been a nightmare in multiple acts. First came complaints of illnesses and injuries caused by the devices. Then came reports of deaths. Then came a large-scale recall that itself was beset by problems.
Now ProPublica has learned of another episode. As Philips struggled to execute its recall in 2022, it turned to its biggest distributor, a company called Lincare, to help ensure that replacement equipment would reach the patients who needed it most. But instead of sending those machines to vulnerable longtime users — what Philips expected — Lincare diverted thousands of machines to new customers, which resulted in greater profits. Some patients did not receive replacement breathing machines for as long as two years. Meanwhile, complaints to the FDA reporting deaths (561) and illnesses, injuries or malfunctions (116,000) associated with the recalled devices continued to climb.
Philips’ problems first surfaced publicly in June 2021, when the company warned that the noise-deadening foam lining its equipment, mostly CPAP machines, could break apart, sending potentially toxic particles and fumes into users’ throats and lungs. (Millions of people use such “continuous positive airway pressure” devices to treat sleep apnea, a condition that causes breathing to stop and start repeatedly during the night.)
Philips announced a recall. The company vowed to stop selling to new customers and dedicate its manufacturing capacity to replacing the recalled devices with safe, redesigned CPAP machines “as expeditiously as possible.” (The Philips recall, and the tangled history that led up to it, were the subject of a series of investigations by ProPublica and the Pittsburgh Post-Gazette.)
But the recall was marred by problems, and by the spring of 2022, many patients hadn’t received replacement devices. Some were informed by Philips that they might have to wait another year, meaning the company would fail to fulfill its plan to swap out all the recalled equipment by the end of 2022. That left even a patient who’d had a double lung transplant waiting for months on end.
Under pressure from the Food and Drug Administration, which regulates medical-device safety, Philips agreed to pursue a “prioritization approach,” providing new equipment first to the “most vulnerable” patients — those who depend on the breathing equipment the most. Philips pledged that all the safe devices it produced would go as quickly as possible to the sickest patients, according to a March 10, 2022, FDA notification order.
Lincare is America’s biggest distributor of breathing equipment. It buys tens of thousands of CPAP machines from Philips and other manufacturers every year, then collects up to 13 months of rental payments for providing them to patients, with Medicare and other insurers picking up most of the tab. Lincare also sells lucrative replacement supplies, such as masks, filters and hoses.